Immunogenicity and Safety of a Quadrivalent Meningococcal Tetanus Toxoid-Conjugate Vaccine (MenACYW-TT) Administered Concomitantly with Other Paediatric Vaccines in Toddlers: a Phase III randomized study

M. S. Dhingra, L. Namazova-Baranova, J. L. Arredondo-Garcia, K.-H. Kim, K. Limkittikul, W. Jantarabenjakul, O. Perminova, I. A. R. Kobashi, C.-W. Bae, J. Ojeda, J. Park, D. Chansinghakul (+4 others)
2021 Epidemiology and Infection  
Invasive meningococcal disease (IMD) has high morbidity and mortality, with infants and young children among those at greatest risk. This phase III, open-label, randomized study in toddlers aged 12-23 months evaluated the immunogenicity and safety of MenACYW-TT, a tetanus toxoid conjugated vaccine against meningococcal serogroups A, C, W, and Y, when coadministered with paediatric vaccines (measles, mumps and rubella [MMR]; varicella [V]; 6-in-1 combination vaccine against diphtheria, tetanus,
more » ... ertussis, polio, hepatitis B and Haemophilus influenzae type b [DTaP-IPV-HepB-Hib] and pneumococcal conjugate vaccine [PCV13])(NCT03205371). Immunogenicity to each meningococcal serogroup was assessed by serum bactericidal antibody assay using human complement (hSBA). Vaccine safety profiles were described upto 30 days post-vaccination. A total of 1,183 participants were enrolled. The proportion with seroprotection (hSBA ≥1:8) to each meningococcal serogroup at Day 30 was comparable between the MenACYW-TT and MenACYW-TT+MMR+V groups (≥92 and ≥96%, respectively), between the MenACYW-TT and MenACYW-TT+ DTaP-IPV-HepB-Hib groups (≥90% for both) and between the MenACYW-TT and MenACYW-TT+PCV13 groups (≥91 and ≥84%, respectively). The safety profiles of MenACYW-TT, and MMR+V, DTaP-IPV-HepB-Hib, and PCV13, with or without MenACYW-TT, were generally comparable. Coadministration of MenACYW-TT with paediatric vaccines in toddlers had no clinically-relevant effect on the immunogenicity and safety of any of the vaccines.
doi:10.1017/s0950268821000698 fatcat:sk6ck5fb7fgl3b6krgqtdo3ca4